Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2026-02-26 @ 12:03 PM
Study NCT ID:
NCT01462760
Status:
UNKNOWN
Last Update Posted:
2011-10-31
First Post:
2011-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010808', 'term': 'Physical Examination'}], 'ancestors': [{'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 85}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2012-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-10-27', 'studyFirstSubmitDate': '2011-10-12', 'studyFirstSubmitQcDate': '2011-10-27', 'lastUpdatePostDateStruct': {'date': '2011-10-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Inclinometer and actigraph assessment', 'timeFrame': 'elbow joint measures are done just at one time point, during the visit', 'description': 'Elbow joint measures by the inclinometer and the actigraph'}], 'secondaryOutcomes': [{'measure': 'Assessment of easily use', 'timeFrame': 'Assessment are done just at one time point, during the visit', 'description': 'Assessment of easily use'}, {'measure': 'Assessment comfort and utility of use', 'timeFrame': 'Assessment are done just at one time point, during the visit', 'description': 'Assessment of comfort and utility of use'}, {'measure': 'measurement time', 'timeFrame': 'Assessment are done just at one time point, during the visit', 'description': 'measurement time'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Geriatric Disorder']}, 'referencesModule': {'references': [{'pmid': '25759568', 'type': 'DERIVED', 'citation': 'Sacco G, Turpin JM, Marteu A, Sakarovitch C, Teboul B, Boscher L, Brocker P, Robert P, Guerin O. Inertial sensors as measurement tools of elbow range of motion in gerontology. Clin Interv Aging. 2015 Feb 23;10:491-7. doi: 10.2147/CIA.S70452. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'In this study, the investigators will measure range of motion of the elbow in a geriatric assessment in 85 subjects aged 65 years or over. These measures will be made by an actigraph and the software analysis BioVal. This technique will be compared with the standard technique (inclinometer). It will also be evaluated during this study, the ease of use and feedback.', 'detailedDescription': "The deterioration of the musculoskeletal system occurring in aging is a major cause of loss of autonomy and directly affects the quality of life of the individual.\n\nSupport and appropriate rehabilitation for the patient's return home is essential. It requires physiotherapy assessment, which includes, among other things, a joint assessment with a measure passive range of motion.\n\nPhysical therapists have different techniques to achieve these measures for each of them, the benefits (time, reliability) and disadvantages. Among them, the goniometer and inclinometer are technical references The main objective of the study is to validate the MotionPod and the software BioVal as valid tool for measuring range of motion of the elbow in a joint geriatric assessment.\n\nSecondary objectives are the study of the reproducibility of the measurement time and ease of use The measurement range of motion in the elbow in degree, estimated by actigraphy and software BioVal will be compared to those obtained with an inclinometer.\n\nThe movements are examined successively flexion, extension, pronation and supination.\n\nThe proportion of valid measurements will be calculated for each movement. The confidence interval 95% partner will also be calculated.\n\nMoreover, in order to judge the validity of actigraphy in all of these measures, the investigators will calculate the proportion of patients for which the measures are valid for all four movements and the confidence interval 95% partner.\n\n85 patients aged 65 years or more will be recruited at the Cimiez hospital the CHU of Nice, in the services of short, medium and long geriatric stay"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prescription of physiotherapy .\n* Prescription of a passive joint assessment\n* Consent to participate in the study signed\n* person with a social security system\n\nExclusion Criteria:\n\n* person with a pacemeker\n* patient with the inability to position the wrist straightness\n* patient with the inability to position the shoulder in neutral\n* metal prosthesis or osteosynthesis\n* patient with a joint debate \\<20 °\n* contraindicated warm up'}, 'identificationModule': {'nctId': 'NCT01462760', 'acronym': 'BIOVAL', 'briefTitle': 'Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Contribution of Actigraphy for the Evaluation of Elbow Range of Motion in the Joint Assessment in Gerontology', 'orgStudyIdInfo': {'id': '11-PP-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'First assessment: inclinometer', 'description': 'First assessment: inclinometer Second assessment: actigraph and inclinometer', 'interventionNames': ['Device: Assessment with inclinometer']}, {'type': 'OTHER', 'label': 'first: Inclinometer and actigraph', 'description': 'first: Inclinometer and actigraph second: inclinometer', 'interventionNames': ['Device: Assessment with inclinometer', 'Device: Assessment with actigraph']}], 'interventions': [{'name': 'Assessment with inclinometer', 'type': 'DEVICE', 'description': 'joint assessment with inclinometer. The inclinometer used in this trial is Baseline® Bubble Inclinometer', 'armGroupLabels': ['First assessment: inclinometer', 'first: Inclinometer and actigraph']}, {'name': 'Assessment with actigraph', 'type': 'DEVICE', 'description': "joint assessment with actigraph The actigraph used in this trial is the Motion Pod. It's an analysis and reeducation systems by biofeedback. The manufacturer is Movea.", 'armGroupLabels': ['first: Inclinometer and actigraph']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06000', 'city': 'Nice', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Delphine DEL CONT', 'role': 'CONTACT', 'email': 'delcont.d@chu-nice.fr'}, {'name': 'Philippe ROBERT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jean-Michel TURPIN, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Centre Memoire Ressources et Recherche, CHU de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'centralContacts': [{'name': 'Philippe ROBERT, PhD', 'role': 'CONTACT', 'email': 'robert.p@chu-nice.fr'}], 'overallOfficials': [{'name': 'Philippe ROBERT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professeur', 'investigatorFullName': 'Del Cont Delphine', 'investigatorAffiliation': 'Centre Hospitalier Universitaire de Nice'}}}}